Nov. 19, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today reported analyses of Phase 3 clinical data showing the impact of OMS302 on reducing the incidence of miosis (pupil constriction) during intraocular lens replacement (ILR). OMS302 is the company's proprietary Pharmacosurgery
® product being developed for all ILR, including cataract surgery and refractive lens exchange.
The analyses were presented by
Steve Whitaker, M.D., Omeros' vice president of clinical development and chief medical officer on
November 17 at the Annual American Academy of Ophthalmology (AAO) Meeting in
New Orleans. The clinical data presented at the AAO meeting and shown below demonstrated that, in these clinical trials in which all patients received standard-of-care preoperative mydriatic topical drops, OMS302 reduced the occurrence of intraoperative pupil constriction. Intraoperative miosis is an important risk factor for surgical complications. As shown in the figure below, pupil constriction of at least 3 millimeters was common in control patients while constriction greater than 1 millimeter was uncommon in OMS302-treated patients.
"We are pleased with the recognition that the recent clinical data for OMS302 received from the ophthalmic community during the AAO annual meetings," said
Gregory A. Demopulos
, M.D., chairman and chief executive officer of Omeros. "Ophthalmologists continue to appreciate the potential clinical benefits of OMS302, and we look forward to the drug's expected commercial launch in 2014."
About Omeros' OMS302 Program
OMS302 is Omeros' product being developed for use during intraocular lens replacement (ILR), including cataract surgery and refractive lens exchange. OMS302 is a proprietary combination of the mydriatic (pupil dilating) agent phenylephrine and the anti-inflammatory agent ketorolac. Omeros' New Drug Application (NDA) for OMS302 has been accepted for filing by the FDA and its Marketing Authorization Application (MAA) for OMS302 has been validated by the EMA.
ILR involves replacement of the original lens of the eye with an artificial intraocular lens. These procedures are typically performed to replace a lens opacified by a cataract or to correct a refractive error of the lens (i.e., refractive lens exchange). OMS302 is added to standard irrigation solution used in ILR and delivered within the eye to maintain intraoperative mydriasis (pupil dilation), to reduce surgically induced miosis (pupil constriction), and to reduce postoperative pain and irritation. Maintenance of mydriasis is critical to the safety and surgical ease of the procedure. Intraoperative pupil constriction increases the risk of injury to intraocular structures and can substantially prolong surgical time.